Breast Cancer Clinical Trial
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Summary
Primary Hypothesis:
1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction
Secondary hypotheses:
The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix
Specific aims:
Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
Compare the complication rates between the two types of acellular dermal matrix
Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation
Eligibility Criteria
Inclusion Criteria:
Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
Female gender
Age between 18 and 80
Consent to participate in the study
Exclusion Criteria:
Patients not undergoing breast reconstruction following mastectomy
Patients undergoing delayed breast reconstruction following mastectomy
Patients undergoing immediate definitive breast reconstruction after mastectomy
Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
Medical debility precluding surgical treatment
Prior breast or chest wall irradiation
Pregnant patients
Male gender
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There is 1 Location for this study
Salt Lake City Utah, 84112, United States
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